Catalog Number

C7523EA

Brand Name

CUSA® Clarity

Version/Model Number

C7523EA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190180

Product Code

LBK

Product Code Name

Device, neurosurgical fragmentation and aspiration

Public Device Record Key

4481aab3-3ae5-41fc-b175-a16c05e4b389

Public Version Date

October 26, 2022

Public Version Number

2

DI Record Publish Date

May 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-